Date of event: date of event was approximated to (b)(6) 2018, as no exact event date was reported.User facility reference number: (b)(4).(b)(4).Captures the reportable event of probe broke.Visual examination of the returned ultrasound probe revealed that it was broken about 10cm from the head.Therefore, a review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event.
|
It was reported to boston scientific corporation on (b)(6) 2018 that a lithoclast 3.8mm x 403mm ultrasound disposable probe was used in a procedure performed on (b)(6)2018.According to the complainant, during the procedure, the ultrasound probe got busted.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.Note: this event has been deemed an mdr-reportable event based on investigation results, which revealed that the ultrasound probe was broken and because of the ambiguity of where the fragments detached.Please refer to block h10 for full investigation details.
|